Kornimate/medical-research-clean huggingface dataset:
project my heart your heart: pacemaker reuse

Conditions: Device Related Infection; Device Malfunction; Bradycardia

Summary: lack of access to pacemakers is a major challenge to the provision of cardiovascular health care in low and middle income countries (lmic). post-mortem pacemaker utilization could be safe, efficacious, and ethically responsible means of delivering the needed care. reconditioned pacemakers can provide therapy for patients with symptomatic bradycardia and no means of receiving a new device. the objective of the clinical trial is to determine if pacemaker reutilization can be shown to be a safe means of delivering pacemakers to patients in lmic without resources. consented patients in this multi-center trial will be randomized to undergo implantation of either a reconditioned device or a new device.


Eligibility criteria:
inclusion criteria: * life expectancy ≥ 2 years. * indications for device implantation must be fulfilled per standard of care. consistent with 2008 american college of cardiology / american heart association guidelines for device therapy, one of the following class i indications must be met. * sinus node dysfunction * acquired atrioventricular (av) block * chronic bifascicular block * hypersensitive carotid syndrome * lack of financial ability to pay for a new device must be assessed and documented. * all other methods of new device acquisition must be exhausted. * patient must be agreeable and able to follow-up with the implanting center within 2 weeks for wound check, at 2 months, 6 months, and every 6 months thereafter for routine pacemaker checks. exclusion criteria: * severe valvular disease * severe pulmonary disease * end-stage renal disease (creatinine clearance \< 30 ml/min) whether or not on dialysis * evidence of ongoing systemic infection * prior pacemaker or implantable cardioverter-defibrillator implantation * significant contraindication to pacemaker implantation per evaluation of the implanting physician (very high risk of complications). * presence of any other condition that the local investigator feels would be problematic or would restrict or limit the participation of the patient for the entire study period * pregnant women
psychological determinants of the therapeutic observance of osteoporotic patients

Conditions: Osteoporosis, Postmenopausal

Summary: osteoporosis is a skeletal pathology characterized by decreased bone mass and deterioration of bone tissue. this pathology affects predominantly women, which is estimated that 40% of them will suffer an osteoporotic fracture. the incidence of osteoporosis, thus representing a major public health problem where osteoporotic fractures have a higher incidence than those combined with cardiovascular disease and breast cancer (inserm, 2016; who 2008). it causes traumatic fractures that have the effect of dependence and loss of functional autonomy associated, in terms, with the risk of a reduction in life expectancy. the management of osteoporosis therefore becomes an issue for rheumatologists. the latter involves both compliance with hygienic-dietetic measures (such as calcium intake, physical activities, prevention of falls...) and medicated treatments whose action is intended, for some, to block bone destruction or, for others to stimulate bone formation. the efficacy of drug treatments is now proven, these treatments are however profitable only if the therapeutic adherence of the patients is maximal. however, rheumatologists and researchers generally find an average rate of 70% enrolment after 6 months of treatment, most often lowered to 50% after 12 months of treatment, thus increasing fractures. on the other hand, the literature informs the medical and educational aspects of the problem of non-observance in osteoporotic patients, but curiously, it does not say anything of the psychological aspects likely to be linked to these behaviors of non-adherence to therapy. the objective of this thesis work is to take an interest in the underlying psychological determinants that may explain the behaviour of adherence and/or non-adherence of osteoporotic patients.


Eligibility criteria:
inclusion criteria: * be treated with an anti-osteoporotic drug for at least three months * mastering the french language orally and in writing * have obtained the patient's oral agreement to participate in the research * present post-menopausal osteoporosis * present a densitometric osteoporosis with a t-score (-2.5) treated medically per os (example: biphosphonates) or by subcutaneous injection (example: prolia) * present a history of severe osteoporotic fractures after falls of its height. exclusion criteria: * present a psychiatric history * present an intellectual disability * present major cognitive disorders related to neurodegenerative disease or other nervous system disorders.

Keywords: osteoporosis adherence to therapy psychological determinants self regulation model
an open label study to evaluate the safety and efficacy of mechlorethamine(mch) 0.04% formulation in mycosis fungoides

Conditions: Mycosis Fungoides

Summary: to evaluate the efficacy and safety of topical application of mch 0.04% in a propylene glycol ointment (pg)in patients with stage i or iia mf previously treated with mch 0.02% in a pg or ap ointment who did not achieve a complete response.

this is a multi-center, open-label study of patients with previously treated stage i (ia and ib) or iia mf who have not received a complete response after completing 12 months of treatment in clinical trial (2005nmmf-201-us)to either 0.02% mch pg or 0.02% mch in aquaphor (ap) ointment formulations.

Eligibility criteria:
inclusion criteria: * patients must have completed the treatment phase of the yaupon therapeutics-sponsored phase ii pivotal study of mch 0.02% in either the pg or ap formulation and have not achieved a complete response. exclusion criteria: * pregnant or nursing females, or males and females of childbearing potential, not using an effective means of contraception
efficacy of a computerized cognitive behavioral treatment for insomnia: increasing access to insomnia treatment to decrease suicide risk

Conditions: Insomnia; Physical Health Functioning; Mental Health Functioning

Summary: insomnia is major problem among operation enduring freedom (oef), operation iraqi freedom (oif), and operation new dawn (ond) veterans. insomnia impacts physical and mental health functioning and is associated with reduced quality of life. cognitive behavioral therapy for insomnia (cbt-i) is one of the most promising treatments for insomnia; however, access to cbt-i is severely limited by a lack of trained clinicians within the veterans health administration (vha) and department of defense (dod). there is a critical need to offer innovative approaches to meet the demand and need for insomnia treatment. leveraging technology to meet treatment demands is consistent with service delivery models based upon stepped care principles. this randomized controlled trial will determine whether a computerized, self-guided, web-based version of cbt-i is efficacious in reducing insomnia symptoms and improving functioning compared to a computerized program control.


Eligibility criteria:
inclusion criteria: 1. age between 18 and 55 2. history of deployment in the global war on terror 3. eligible to receive care through va echcs 4. reliable access to the internet 5. english speaking 6. able to provide informed consent 7. current insomnia diagnosis as defined by diagnostic and statistical manual of mental disorders 5 (dsm 5) criteria exclusion criteria: 1. currently enrolled in/participating in other intervention research studies 2. other untreated sleep disorders (e.g., sleep apnea, periodic limb movement) 3. currently receiving formal psychological treatment for insomnia (not including sleep medications) 4. past 3 month change in schedule and/or dosage of medications that are designed to improve/impact sleep 5. history of bipolar disorder (with manic episodes), schizophrenia, schizoaffective disorder, or a psychotic disorder 6. untreated seizures or seizure disorder 7. physical illness that is active, unstable, degenerative, and/or progressive 8. currently pregnant or plan to become pregnant in the next 6 months 9. irregular work schedule, shift work, and/or life changes (e.g., new baby) interfering with regular sleep patterns 10. significant cognitive impairment, as determined by chart review and/or during screening, that would interfere with ability to engage in shuti 11. current non-alcohol substance use disorder, excluding cannabis use disorder, as determined by chart review and/or self-report screen of drug use (\> 1 time) in past 3 months 12. current alcohol use diagnosis, as determined by scid 5 module, in the past 3 months

Keywords: cbt-i insomnia
effect of interscalene and suprascapular nerve block on analgesia consumption after adhesive capsulitis surgery

Conditions: Shoulder Surgery

Summary: in this study, a combination of different types of blocks for adhesive capsulitis surgery, the investigators will investigate the impact on patient satisfaction and analgesic consumption after surgery.

general anesthesia will be performed in all patients for arthroscopic adhesive capsulitis shoulder surgeries. in the first group of patients (group ipsb), interscalene brachial plexus block will be applied 30 minutes before surgery, while interscalene brachial plexus block and suprascapular nerve block (ssnb) administration to the second group patients (group ssnb) before surgery. patients in the third group (group c) will be considered the control group and no block will be performed. patient-controlled analgesia (pca) with morphine will be used in all three groups for postoperative analgesia. preoperative hemodynamic data of patients, postoperative pain scores (vas), morphine consumption, patient satisfaction score, requirement of additional analgesia and observed side effects were recorded. consumption of analgesia 24 hours after surgery and patient satisfaction will be evaluated.

Eligibility criteria:
inclusion criteria: * asa i- asa ii patients exclusion criteria: * history of allergy to the study medication * refusal to participate

Keywords: suprascapular nerve block interscalene brachial plexus block ultrasound patient satisfaction score analgesic consumption
tumor treating fields (ttf) in combination with stereotactic radiosurgery(srs) for brain metastases from non-small cell lung cancer.

Conditions: NSCLC Brain Metastasis

Summary: this is a randomized, controlled, open-label, phase iii trials. the main purpose of this study is to evaluate the effectiveness and safety of tumor treating felds (ttf) combined with stereotactic radiosurgery (srs) in the treatment of brain metastases from non-small cell lung cancer (nsclc) .


Eligibility criteria:
inclusion criteria: 1. the age of the subject was between 18 and 75 years old (inclusive), regardless of gender; 2. the predicted survival time was ≥3 months; 3. newly diagnosed with nsclc brain metastasis; 4. mri imaging showed 1-10 unresectable brain metastases; 5. karnofsky performance status (kps) score ≥70; 6. able to operate the ttf independently or with the help of a caregiver; 7. subjects of childbearing potential had to agree to use effective contraception for the duration of the trial; 8. voluntarily signed the informed consent form. exclusion criteria: 1. positive driver genes; 2. recurrent brain metastasis of nsclc; 3. suffering from severe cerebral edema; 4. leptomeningeal metastases; 5. participants had to meet certain criteria for bone marrow, liver and kidney function before enrollment, and were not eligible if they had any of the following: 1. platelet count \< 100×103/μl; 2. absolute neutrophil count \< 1.5×103/μl; d. ast or alt exceeding 2.5 times the upper limit of normal; c.total bilirubin more than 1.5 times the upper limit of the normal range; d.severe renal impairment (serum creatinine \>1.7 mg/dl, or \>150 μmol/l); 6. there were infection, ulcer and unhealed wound in the skin where the electrode was applied； 7. patients allergic to conductive hydrogels or medical adhesives; 8. those who are pregnant or preparing to become pregnant or who are breastfeeding; 9. patients with poor compliance, as judged by the investigator, or other factors considered by the investigator to be not suitable for the study.

Keywords: ttf nsclc brain metastasis
effect of ro6871765 and ro7011785 on immune response with the stimulation of peripheral blood mononuclear cells (pbmcs) in chinese healthy volunteers and chronic hepatitis b patients

Conditions: Hepatitis B, Chronic

Summary: this is an exploratory study to characterize the ex vivo immune response to ro6871765 or ro7011785 stimulation of peripheral blood mononuclear cells (pbmcs) extracted from healthy volunteers and chronic hepatitis b (chb) patients.


Eligibility criteria:
inclusion criteria: all population: * chinese population * adequate hematological function: platelet count greater than or equal to (\>=) 100\*10\^9 per liter (/l), hemoglobin (hb) \>= 12 grams/deciliter (g/dl) (male) or \>= 11 g/dl (female), white blood cell (wbc) count \>= 4\*10\^9/l and \<= 11\*10\^9/l healthy volunteers: * absence of evidence of any active or chronic disease * negative hepatitis b virus deoxyribonucleic acid (hbv dna), hepatitis b surface antigen (hbsag), hepatitis b surface antibody (hbsab), hepatitis b envelope antigen (hbeag), hepatitis b envelope antiody (hbeab) and hepatitis b core antibody (hbcab) * adequate liver function: transaminases alanine aminotransferase (alt) \<= 1.0 times the upper limit of normal (uln) treatment naïve chb patients: * hbsag-positive (\>=250 international unit/milliliter \[iu/ml\]), compensated liver function, non-cirrhotic * hbeag-positive, hbv dna \>= 200,000 iu/ml or equivalent copies/ml, alt \>1.5 times the uln and alt \<8 times the uln hbeag-negative nucleoside/nucleotide analogue-treated chb patients: * subjects who hbeag-seroconverted on nucleoside/nucleotide analogue therapy (treatment for 1 to 3 years prior to enrollment) with hbv dna \<90 iu/ml or below a detection level acceptable by both the sponsor and investigator for at least the preceding 6 months; hbeag negative and hbeab positive * hbsag-positive (\>=250 iu/ml), compensated liver function, non-cirrhotic -alt \<= 1\*uln exclusion criteria: * use of steroids or other immune suppressive agents within the last 4 weeks that would impact the number/functions of white blood cells (wbc) * any other diseases or clinical laboratory finding giving reasonable suspicion of a disease or condition (including, but not limited to, cancer, lupus erythematosus, rheumatoid arthritis, or other autoimmune disease) that could confound the result of the study * positive hepatitis a immunoglobulin m (igm) antibody, hepatitis c antibody (hcv ab) or human immunodeficiency virus (hiv) at screening * significant acute infection, example; influenza, acute gastrointestinal symptoms or any other clinically significant illness within 2 weeks * previous/concurrent treatment with interferon-based therapy for chb
trial to evaluate steady state pharmacokinetic parameters, efficacy and safety of nevirapine in antiretroviral drug naïve pediatric patients

Conditions: HIV Infections

Summary: trial to evaluate steady state pharmacokinetic parameters of nevirapine 150mg/m2 and nevirapine 4 or 7 mg/kg after 4 weeks, and efficacy and safety of the dosing when administered for 48 weeks in antiretroviral drug naïve paediatric patients.

a randomised open label multi-centre trial to evaluate the pharmacokinetic, efficacy and safety parameters of nevirapine 150mg/m2 and nevirapine 4 or 7mg/kg when administered in combination with zdv and 3tc for 48 weeks in antiretroviral naive pediatric patients. primary objective: to evaluate steady state pharmacokinetic parameters of nevirapine 150mg/m2 in antiretroviral drug naive pediatric patients. secondary objective: to assess efficacy and safety of nevirapine 150 mg/m2 and nevirapine 4/7mg/kg after 24 and 48 weeks of treatment study hypothesis: evaluation of recent pharmacokinetic data has suggested that a dose based on body surface area rather than body weight might be a better therapeutic regimen to achieve steady state plasma concentrations. the goal in this study was to determine if a nevirapine suspension dose of 150 mg/m2 bid, following a two week lead-in of 150 mg/m2 qd, produces plasma nevirapine steady state concentrations of 4 - 6 ?g/ml in all age groups as was observed in adult safety and efficacy trials. comparison(s): actg 245

Eligibility criteria:
inclusion: 1. male or female patients between 3 months and 16 years of age at day 28 of the study. 2. evidence of hiv-1 infection 3. patients who are antiretroviral drug naive 4. plasma viral load detectable 5. cd4 \>=50 cells/cc3 6. written informed permission 7. active assent given by the patient if the child is capable of understanding the given information 8. reasonable probability for completion of the trial exclusion: 1. any significant disease, other than hiv 2. any acute illness within 2 weeks prior to day 0 3. patients requiring the continued use of inhibitors or inducers of p450 metabolic enzymes 4. patients requiring systematic treatment with cyp3a4 substrates 5. patients with malabsorption, severe chronic diarrhea 6. receipt of any cytotoxic therapy for malignancy 7. current grade 3 or 4 clinical or laboratory toxicity 8. pregnancy or breast-feeding 9. females of childbearing potential not using adequate contraception. allergy or known drug hypersensitivity to any of the study drugs intravenous drug abuse, alcohol or substance abuse
analgesic properties of oral sucrose during immunizations

Conditions: Procedural Pain

Summary: the purpose of this study is to examine the analgesic properties of oral sucrose during routine immunizations. hypothesis: oral sucrose solution and maternal contact will significantly decrease the objective measures of acute pain during routine immunizations.

the purpose of this study is to examine the analgesic properties of oral sucrose during routine immunizations. hypothesis: oral sucrose solution and maternal contact will significantly decrease the objective measures of acute pain during routine immunizations. acute pain during early life may alter infant pain responses, cognitive development and behavioral outcomes. infants respond to immunizations with significant pain and distress. this study will examine the analgesic properties of oral sucrose and maternal holding in postnatal infants. comparison: administration of oral sucrose, sterile water and maternal contact 2 minutes before routine immunizations.

Eligibility criteria:
inclusion criteria: 1. currently between 4 and 11 months of age; 2. between 37 and 42 weeks' completed gestation at birth; 3. birth weight greater than 2.5 kg; and 4. no evidence of acute or chronic disease exclusion criteria: 1. fed 30 minutes prior to immunization; 2. received analgesic/sedative the day of the immunizations; 3. parent wishes to feed the infant during the immunizations; 4. infant is diagnosed with a major congenital disorder where the behavioral responses to painful stimuli may be altered; or 5. language barriers preclude the process of obtaining parental consent.

Keywords: pain procedural pain sucrose infant
study of an investigational glucose meter system

Conditions: Diabetes

Summary: the purpose of this study is to demonstrate that untrained subjects who have diabetes or pre-diabetes can operate the investigational blood glucose monitoring system (bgms) and obtain valid glucose results.


Eligibility criteria:
inclusion criteria: * have a diagnosis of diabetes or pre-diabetes. * be 18 years of age or older * be able to speak, read and understand english and understand the informed consent document. * be willing to complete study procedures exclusion criteria: * pregnancy * infections or skin disorders at the site of the venipuncture (at the discretion of the phlebotomist). * hemophilia, bleeding disorder, or clotting problems. persons taking aspirin (81 mg or 325 mg) daily or plavix® are not reason for exclusion. * physical (dexterity), visual, or neurological impairments that would make the person unable to perform testing with the bgm (at the discretion of the site professional staff). * a condition, in the opinion of the investigator, would put the subject at risk or influence the conduct of the study or interpretation of the results. the reason for exclusion will be documented by the professional staff. * previously participated in a blood glucose monitoring study using a similar device or use a similar device for personal use when monitoring blood glucose. * working for a competitive medical device company or having an immediate family member or someone who is not a family member but is living within the household of someone who works for such a company * working for a medical laboratory, hospital or other clinical setting that involves training on and clinical use of blood glucose monitors
long-term atrial pacing and central blood pressure

Conditions: Blood Pressure

Summary: this is a randomized controlled single-centre clinical trial with a cross-over design to compare non-invasively evaluated central blood pressure and related parametres in sick sinus syndrome patients with hypertension who are paced long-term at a slower vs faster heart rate


Eligibility criteria:
inclusion criteria: * age 18-80 years * sick sinus syndrome * permanent cardiac pacemaker with right atrial and right ventricular leads * at least 3 months from implantation * sinus rhythm * percentage of atrial pacing at or above 80% since last interrogation * percentage of ventricular pacing at or below 3% since last interrogation * primary arterial hypertension * antihypertensive drug treatment * mean office brachial blood pressure below 140/90 mmhg * mean home brachial blood pressure below 135/85 mmhg * ability to understand and follow study protocol * signed informed consent form exclusion criteria: * inclusion criteria not fulfilled * violation of study protocol by subject, investigator or third part * high quality central hemodynamic measurements cannot be perfomed * inter-arm difference in brachial systolic blood pressure 15 mmhg or above * intrinsic qrs complex 130 ms or above * more than three antihypertensive agents in use * treatment with digoxin or agents from vaughan-williams classes ic, iii või iv * frequent high atrial rate episodes * coronary artery disease * secondary hypertension * resistant hypertension * orthostatic hypotension * heart failure with decreased or preserved left ventricular ejection fraction * implantable cardioverter-defibrillator or cardiac resynchronization therapy * significant valvular heart disease * significant congenital heart disease * body mass index ≥35 kg/m2 * type i diabetes * type ii diabetes with cardiovascular complications or on insulin therapy * other significant endocrine disease * history of cerebrovascular attack * carotid artery disease * lower extremity arterial disease * severe chronic obstructive pulmonary disease * severe asthma * severe sleep apnea * interstitial pulmonary disease * inhaled beta adrenergic agonist therapy * active cancer treatment * central nervous system degenerative disease * systemic connective tissue disease * abnormal tsh at present * glomerular filtration rate ≤30 ml/min/m2 * hemoglobin \<100 g/l (female), \<110 g/l (male) * hepatic dysfunction * alcohol abuse * pregnancy or breastfeeding * no health insurance provided by estonian health insurance fund * withdrawal of informed consent * loss of contact with a subject during study

Keywords: central blood pressure sick sinus syndrome pacemaker hypertension sinus node dysfunction